NCT00739115

Brief Summary

The purpose of this study is to evaluate the safety and utility of using heliox gas in combination with nasal CPAP in premature infants. The investigators hypothesize that using heliox gas in combination with nasal CPAP will results in decreased early nasal CPAP failure requiring intubation and mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

August 20, 2008

Last Update Submit

August 25, 2015

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

RespiratoryDistressPrematurityHelioxCPAP

Outcome Measures

Primary Outcomes (1)

  • Nasal CPAP failure resulting in endotracheal intubation

    72 hours of life

Secondary Outcomes (5)

  • Bronchopulmonary dysplasia

    36 weeks corrected gestational age

  • Hospital length of stay

    At hospital discharge

  • Death

    Prior to hospital discharge

  • Pulmonary interstitial emphysema

    72 hours of life

  • Pneumothorax

    72 hours of life

Study Arms (2)

1

EXPERIMENTAL

Heliox gas added to nasal CPAP for the first 72 hours of life

Other: Heliox gas

2

NO INTERVENTION

Conventional nasal CPAP for the first 72 hours of life

Interventions

Heliox gasOTHER

Heliox gas used in conjunction with nasal CPAP

1

Eligibility Criteria

Age1 Minute - 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age \< 33 weeks
  • Receiving CPAP from the time of delivery

You may not qualify if:

  • Cyanotic congenital heart disease
  • Congenital malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Taylor Sawyer, DO

    Kapiolani Medical Center For Women & Children

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

US(1)